A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)

Phase 3

Completed

• Conditions: Non-Small-Cell Lung Cancer
• Interventions: Drug: Zoledronic acid 4 mg

• Registration Number: NCT00172042
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Results First Submitted: 2011-06-16
• Results First Submitted QC: 2011-06-16
• Results First Posted: 2011-07-19
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 437

Inclusion Criteria

• Histologically or cytologically confirmed Non-small Cell Lung Cancer (NSCLC)
• Newly Diagnosed, Stage IIIA and Stage IIIB excluding patients with pleural effusion
• Patients must have received primary treatment for their disease and had no progression

Exclusion Criteria

• Diagnosed with NSCLC longer than 6 months ago
• Treatment with other bisphosphonates in past 12 months
• Presence of metastases

Other protocol-defined inclusion and exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronic acid	Zoledronic acid 4 mg	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
Control	Zoledronic acid 4 mg	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	Up to 24 months	Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Kaplan-Meier Estimates for Progression-free Survival	Months 6, 12, 18, and 24	Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Percentage of Participants With Progression-Free Survival Events	Up to 24 months	Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months	Months 6, 12, 18 and 24	Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).
Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases	Months 6, 12, 18, and 24	Time to occurrence of bone metastases was defined as the time from randomization to the date of the first documented bone metastases which could be asymptomatic or symptomatic at the time of detection. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).
Kaplan-Meier Estimates for Overall Survival	Months 6, 12, 18, and 24
Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry	Months 12 and 24	Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.
Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)	Months 6,12, 18, and 24	Time to the first skeletal related event defined as the time from randomization to the date of occurrence of the first SRE. Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Sutton, United Kingdom